A Randomized, Phase 2 Study of the Efficacy and Tolerability of Veliparib in Combination With Temozolomide or Veliparib in Combination With Carboplatin and Paclitaxel Versus Placebo Plus Carboplatin and Paclitaxel in Subjects With BRCA1 or BRCA2 Mutation and Metastatic Breast Cancer
The main purpose of the study is to determine if patients with BRCA1 or BRCA2 mutation and metastatic breast cancer can do better with veliparib in combination with temozolomide or carboplatin and paclitaxel with or without veliparib.
Stanford is not currently accepting new patients for this trial. You may want to check clinicaltrials.gov to see if other locations are recruiting.
- drug : Temozolomide
- drug : Veliparib
- drug : Placebo
- drug : Paclitaxel
- drug : Carboplatin
Phase: Phase 2
Ages Eligible For Study:
- Histologically or cytologically confirmed breast cancer that is either locally recurrent or metastatic. - Locally recurrent disease must not be amenable to surgical resection or radiation with curative intent. - Must have a documented deleterious Breast Cancer Gene BRCA1 or BRCA2 germline mutation. - If Human Epidermal Growth Factor Receptor (HER2) positive, subjects must have received and progressed on at least one prior standard HER2 directed therapy or the subject must be ineligible to receive anti-HER2 therapy. - Measurable or non-measurable (but radiologically evaluable) disease by RECIST (Response Evaluation Criteria in Solid Tumors) criteria 1.1. - Eastern Cooperative Oncology Group (ECOG) Performance Score of 0-2. - Subject must have adequate bone marrow, renal and hepatic function. - Subject must not be pregnant or plan to conceive a child.